Prime Service Manual PN54460A (2020 - 08 - 20 02 - 50 - 44 UTC)

54460
Stat Profile® PRIME™

CCS Analyzer
Service Manual
Preface Prime Service Manual
Stat Profile® Prime™ CCS Service Manual

Part Number and Ordering Information
The Stat Profile® Prime™ CCS Service Manual can be ordered from Nova Biomedical
Corporation Order Services. Write or call:
Nova Biomedical Corporation
200 Prospect Street
Waltham, MA 02454-9141
U.S.A.
Tel: 1-800-458-5813 FAX: (781) 893-6998 (in the U.S.A.) or
(781) 899-0417 (outside the U.S.A.)
Technical Assistance (USA)

For technical assistance, call Nova Biomedical Technical Services at:
Tel: 1-800-545-NOVA or FAX: (781) 894-0585

(781) 894-0800
Trademarks
Stat Profile® is a registered trademark of Nova Biomedical Corporation.
Prime™ is a trademark of Nova Biomedical Corporation.
Copyright
Printed in the U.S.A. Copyright 2014, Nova Biomedical Corporation, Waltham, MA 02454.
III
Preface Prime Service Manual
IV
Stat Profile Prime Service Manual
Contents
1.0 Introduction 1-1
1.1 Specifications............................................................................................................1-1
1.2 Cautions and Hazards..............................................................................................1-2
1.3 Required Tools..........................................................................................................1-3
2 Analyzer Components 2-1

2.1 Electronics................................................................................................................2-1
2.1.1 Power Supply................................................................................................2-1
2.1.2 GUI Board.....................................................................................................2-1
2.1.3 Main Board...................................................................................................2-2
2.2 Fluidic System..........................................................................................................2-3
2.2 Main Component Identification ................................................................................2-4
3.0 Replacement Procedures 3-1

3.1 Cover Removal.........................................................................................................3-1
3.2 Sampler Assembly Replacement..............................................................................3-2
3.3 Rotary Valve Replacement.......................................................................................3-3
3.4 Coil............................................................................................................................3-4
3.5 Main Board...............................................................................................................3-5
3.6 GUI Board.................................................................................................................3-6
3.7 RFID Board...............................................................................................................3-7
3.8 Cooling Fan..............................................................................................................3-7
3.9 Nest Housing ...........................................................................................................3-8
3.10 Sensor Module Door.................................................................................................3-9
3.11 Internal Tubing Harness..........................................................................................3-10
4.0 Troubleshooting 4-1

4.1 Event Log..................................................................................................................4-2
4.2 Resolving Event Codes............................................................................................4-2
4.2.1 Flow Event Codes............................................................................................4-3
4.2.2 Printer Event Codes.........................................................................................4-6
4.2.3 Micro Sensor Card Event Codes.....................................................................4-7
4.3 Troubleshooting Flow Problems.............................................................................4-10
4.4 2-Point Calibration Sequence.................................................................................4-10
4.5 Analysis Sequence.................................................................................................4-10
4.6 Service Menu.......................................................................................................... 4-11
4.7 The Flow Path Flush Tool.......................................................................................4-18
4.7.1 Flushing the Flowpath.................................................................................4-19
4.7.2 Flushing the Sample Probe/S-Line.............................................................4-20
4.7.3 Flow Test.....................................................................................................4-21
4.8 Software Updates...................................................................................................4-22
4.9 Long Term Shutdown..............................................................................................4-23
TOC-1
PN 54460 Rev. A 2014/07
Table of Contents
TOC-2
1 Introduction
1.0 Introduction
1. Intro.
This manual contains information and procedures for use in servicing the Stat
Profile Prime series analyzers. The information in this manual supplements the in-
formation found in the Instructions For Use manual (PN 52920) and the Advanced
User Applications manual (PN 53623).
1.1 Specifications
Working Area Requirements (Environmental):
Keep the working area around the system free of dirt, corrosive fumes, vibration,
and excessive temperature changes.
Electrical Requirements:
• Operating Voltage Range: 90 - 270 VAC
• Operating Frequency: 47 - 63 Hz
• Power Consumption: Less than 100 Watts
Ambient Operating Temperature:

• 15°C to 30°C (59°F to 86°F)
Operate at Humidity:
• 20 to 85% without condensation
Operate at Altitude:
• Up to 12,000 feet/3650 meters
Dimensions:
• Height: 15.4 in (39.1 cm)
• Width: 12.0 in (30.5 cm)
• Depth: 14.4 in (36.2 cm)
Weight:
• 17.5 lb (8.164 kg) without reagent pack
• 23 lb (10.45 kg) with full reagent pack
1-1
Prime Service Manual
Lifting the Analyzer:

1. One person is needed to lift the analyzer.
CAUTION: Never use the door (open or closed) to assist you in lifting the
analyzer. The door cannot support the weight of the analyzer.
2. From the front of the analyzer, place your hands under each side of the analyzer.
3. Lift the analyzer. Remember to bend your knees and lift with your legs and
not your back.
4. Place the analyzer onto a clean and flat surface.
1.2 Cautions and Hazards

There are NO user serviceable assemblies inside the analyzer. Only trained, au-
thorized service representatives should remove the cover of the Prime Analyzer.
WARNING: Removal of the top cover allows access to power supply voltages.
Care should be taken to avoid electrical shock. Remove the power
cord prior to accessing any internal assemblies.
WARNING:
Blood samples and blood products are potential sources of
hepatitis and other infectious agents. Handle all blood products
and flow path components (waste-line, safety sample port,
probe, micro sensor card, etc.) with care. Gloves and protective
clothing are recommended. When performing maintenance and
troubleshooting procedures, also use protective eyewear.
NOTE: This International Caution Label appears on the rear of the Analyzer
and means refer to the manual. It is the responsibility of the service
representative to decontaminate any assembly or analyzer being
returned to Nova for repair or warranty claim.
Decontamination of the external surfaces of the flow path may be accomplished by

wiping down with a cleaning agent or 10% bleach solution. The Internal surfaces
of the flow path and tubing should always be considered contaminated. Prior to
removal from the analyzer, ensure the flow path and tubing are emptied.
WARNING: Internal surfaces may have sharp edges. Care should be taken to
avoid cuts and scrapes when accessing internal assemblies. Used
tubing, sensor cards, reagents, controls, etc. may be disposed by
normal laboratory waste procedures.
1-2
1 Introduction
1. Intro.
1.3 Required Tools
No special tools are required to service the analyzer. A Digital Volt Meter, Phillips
Head screwdriver, small Needle Nose pliers, and a Hex wrench set (SAE Sizing)
are recommended.
1-3
1-4
2 Analyzer Components
The analyzer is designed to be on at all times. It may be shut down for short pe-
riods of time without taking any precautionary steps. If the analyzer will be shut
2. Anal Comp
down for an extended period of time, the internal fluidics should be flushed with
deionized water and air. Also, remove the pump tubing from around the peristaltic
pump.
2.1 Electronics
The analyzer electronics can be broken down into the following main components:
• Power Supply
• GUI Board
o Display
o SD Card
o Bar Code Reader
o USB Port
• Main Board
o Analyzer Control
o Analog to Digital conversion
o Motor Control
o RFID Card readers
2.1.1 Power Supply

The power supply is an external power supply that operates at 90 – 270 volts,
47 – 63 hertz with a power consumption of less than 100 watts. The power supply
produces 24VDC which is regulated on the Main Board to 12VDC, 5VDC, -5VDC,
3.3VDC and 2.5VDC.
2.1.2 GUI Board

The GUI (Graphical User Interface) Board controls the LCD display and touch
screen panel as well as the printer and bar code scanner. The GUI board also con-
tains an external USB port used to install analyzer software and a speaker to pro-
vide audio feedback from the user interface. A removable micro SD card contains
the analyzer configuration, QC, and Patient data and can be removed and installed
in a replacement GUI board if the original board were to fail.
2-1
2.1.3 Main Board

The Main Board controls most of the analyzer’s non-display related functions
including analyzer control signals, Analog to Digital (ADC) control, and control of
the Electro-Mechanical assemblies’ (sampler, pump, rotary valve, printer, heater,
and fan). Three RFID Boards are monitored by the Main board to read and to write
to the RFID chip located on the analyzer’s Calibrator Cartridge, Sensor Card, and
Internal QC Cartridge.
A separate microcomputer contained on the Main board manages the analog to
digital conversion of signals from the sensor module, heaters, and air detectors.
Figure 2.1 Prime Interconnect Diagram
2-2
2.2 Fluidic System

Fluid flow through the analyzer is controlled by a Peristaltic Pump, Rotary Valve,
and Sampler Assembly and Air Detectors.
Calibrators A, B, F, and Internal QC level 1, 2, and 3 are pulled by the peristaltic
2. Anal Comp
pump from their respective cartridge to the rotary valve. The rotary valve is posi-
tioned to pass each fluid through the rotary valve manifold and out the common
(center) port. A common line connects this port to the fluid fountain located on the
sampler assembly.
The sampler is positioned on top of the fluid fountain with an airtight seal provided
by the capillary adaptor or extended to allow sampling from an external container.
The peristaltic pump moves the fluid up the sample probe and s-line into the refer-
ence sensor and past the sensors in the Sensor Cartridge.
After analysis fluids are pumped through an internal waste line into a waste bag
located in the calibrator cartridge. The waste is disposed of when the calibrator
cartridge is removed for replacement.
Reference solution is pumped directly from the calibrator cartridge into the refer-
ence sensor where it mixes with waste fluids and is pumped into the waste bag.
Figure 2.2 Prime Flowpath
2-3
2.2 Main Component Identification
4
5
1. Bar Code Scanner (PN 52892) 4. Sensor Module Door (PN 52884)
2. GUI Board with Display (PN 52896) 5. Sampler Assembly (PN 52887)
3. Peristaltic Pump (PN 52886) 6. Thermal Printer not shown (PN 49588)
Figure 2.3A Main Component Identification: Shown with inner door cover removed
2-4
2. Anal Comp
3
5
2 4
1. Sensor Module Door (PN 52884) 4. Reference Sensor

2. Sensor Card Nest Assembly 5. Sampler Assembly (PN 52887)
3. Peristaltic Pump (PN 52886)
Figure 2.3B Main Component Identification
2-5
3
1
1. Sampler Assembly (PN 52887)

2. Rotary Valve (PN 52888)
3. Coil Assembly (PN 52889)
4. RFID Board (Internal QC) (PN 52897)
Figure 2.3C Main Component Identification
2-6
2. Anal Comp
2
1. Coil Assembly (PN52889)

2. Cooling Fan (PN52891)
3. Main Board (PN52895)
4. Internal QC Manifold with Tubing (PN53026)
Internal QC Tubing Only (PN52616)
5. Calibrator Cartridge Tubing (PN52617)
Figure 2.3D Main Component Identification
2-7
3
1
1. Main Board - (PN52895)

2. RFID Board (Calibrator Cartridge) – (PN52897)
3. USB Connector (Software Updates Only)
Figure 2.3E Main Component Identification
2-8
3 Replacement Procedures
3.0 Replacement Procedures

The replacement procedures in this section describe a method for removing the
primary components that make up the analyzer. To reinstall the component follow
the steps in reverse order.
3.1 Cover Removal

The analyzer cover is secured to the
chassis with 5 Phillips head screws
3. Replace.
located on the rear panel.
1. Remove the screws and slide the

cover backwards to disengage
from the chassis.
Figure 3.1 Remove Screws from Back Cover
2. Disconnect the printer cable from the

Main Board then sit the cover aside.
Figure 3.2 Disconnect the Printer Cable
3-1
3.2 Sampler Assembly Replacement

The Sampler is replaced using the following procedure.
1. Unplug the analyzer and remove the Calibrator and Internal QC Cartridges.
2. Remove the analyzer cover and set aside.
3. Disconnect the J3 cable (lower position on the Sampler Assembly connector
board).
4. Disconnect the Common Line from the base of the Fluid Fountain.
5. Disconnect the Sample Line from the Reference Sensor and unplug AD50.
6. Remove the 4 indicated mounting screws and lift the Sampler free of the
analyzer.
J3
Figure 3.3 Sampler Replacement
3-2
3.3 Rotary Valve Replacement

The Rotary Valve is replaced using the following procedure.
3. Replace.
Figure 3.4 Rotary Valve Replacement
2. Remove the analyzer cover and set it aside.
3. Disconnect the J20 and J24 cable from the Main Board.
4. Using a tubing removal tool, carefully disconnect the tubing attached to the
Rotary Valve manifold.
5. Remove the 3 indicated mounting
screws securing the Rotary Valve
to the chassis. Two located on the
right side of the assembly and one
located on the upper left corner just
below the sampler assembly.
Figure 3.5 Disconnect the J20 and J24 Cables

NOTE: Although not necessary, removing the Sampler assembly first makes the
removal and replacement of the Rotary Valve assembly much easier.
3-3
3.4 Coil
The Coil Assembly is replaced using the following procedure.
1. Unplug the analyzer, remove the cover, and set it aside.

2. Disconnect the B1 and B2 tubing segments from the Coil.
3. Disconnect the Coil cable from J25 on the Main Board
4. Remove the 2 Phillips head mounting screws and remove the coil from the
analyzer.
B2
J25
B1
Figure 3.6 Coil Replacement
3-4
3.5 Main Board

The Main Board is replaced using the following procedure.
2. Disconnect all cables from both sides of the Main Board.
3. Remove 3 mounting screws securing the board to the chassis.
4. Detach the lower left corner of the board from spring loaded mounting pin and
remove from the analyzer.
3. Replace.

Figure 3.7 Main Board Replacement
NOTE: Some ribbon cables are secured with a locking cap to prevent the
cable from coming loose
accidentally. Use caution
when removing a locking cap
to avoid damaging the cable
or the circuit board. Use a
thin, flat-blade screwdriver to
pry the cap off the connector
as shown.
WARNING: NEVER REMOVE cables

by pulling directly on the
wires. PULL the cable
connector ONLY.
Figure 3.8 Using a Screwdriver to remove Locking Cap
3-5
3.6 GUI Board

Use the following procedure to replace the
GUI Board/Display Assembly.
1. To access the GUI Board first remove

the 5 indicated mounting screws
holding the protective cover in place.
Figure 3.9 Remove the 5 Mounting Screws
2. Disconnect the Bar Code

Scanner cable if installed.
3. Disconnect the display cable
connected to J8 on the Main
board.
4. Remove the 4 indicated
mounting screws that secure
the GUI Board/Display to the
door and carefully remove the
assembly from the analyzer.
Figure 3.10 Remove the 4 Board Moun
NOTE: Some ribbon cables are secured with a locking cap to prevent the
cable from coming loose
accidentally. Use caution
when removing a locking cap
to avoid damaging the cable
or the circuit board. Use a
thin flat blade screwdriver to
pry the cap off the connector
as shown.
WARNING: NEVER REMOVE cables

by pulling directly on the
wires. PULL the cable
connector ONLY.
Figure 3.11 Using a Screwdriver to remove Locking Cap
3-6
3.7 RFID Board

Use the following procedure to replace the Calibrator Cartridge or Internal QC
Cartridge RFID Board.
NOTE: To replace the Sensor Cartridge RFID board, you must replace the
Sensor Module Door assembly.

2. Locate the Calibrator Cartridge RFID Board on the left side of the analyzer or
3. Replace.
the Internal QC RFID Board on the right side of the analyzer.
3. Disconnect the cable connected to J2 on the RFID board. Then remove the
2 mounting screws to remove the board.
NOTE: When reinstalling the RFID board insure the circular RFID antenna is
facing the access hole in the chassis.
3.8 Cooling Fan

Use the following procedure to re-
place the cooling Fan Assembly.
1. Disconnect the Fan cable from

the Main Board at J22.
2. Remove the 4 indicated
mounting screws to detach
the fan and mounting plate
assembly from the chassis.
3. Remove the 4 mounting bolts
and nuts that secure the fan
to the bracket.
Figure 3.12 Cooling Fan Assembly Removal
3-7
3.9 Nest Housing

Use the following procedure to replace the Nest Housing.
Figure 3.13 Remove the 3 Hex Screws
1. From the analyzer Maintenance Screen select Menu, Replace Sensor Card,
and wait for the pump to stop.
2. Unplug the analyzer and open the Sensor
Module door. J7
3. Remove the Sensor Cartridge and Reference
Sensor.
4. Use a 7/64 hex wrench to remove the 3
indicated mounting screws. Then carefully
detach the Nest from the chassis. J1
5. Disconnect Reference/Hct board cable from J1.
6. Disconnect the Sensor Connector board
cable from J7.
Figure 3.14 Disconnect Cables J1 and J7
NOTE: Use caution when reinstalling the Sensor Nest to avoid pinching the
ribbon cables between the nest and the
chassis.
NOTE: Some ribbon cables are secured with
a locking cap to prevent the cable from
coming loose accidentally. Use caution
when removing a locking cap to avoid
damaging the cable or the circuit board.
Use a thin flat blade screwdriver to pry
the cap off the connector.
Figure 3.15 Using a Screwdriver to Remove Locking Cap
3-8
3.10 Sensor Module Door

Use the following procedure to replace the Sensor Module Door assembly.
1. From the analyzer Maintenance Screen select Menu, Replace Sensor Card,
and wait for the pump to stop.
3. Disconnect the Sensor Module Door cable from J7 on the Main Board
4. Open the Sensor Module door and use a 7/64 hex wrench to remove the 4
indicated mounting screws: one in each corner.
3. Replace.
5. Carefully detach the assembly from the chassis.
J7
Figure 3.15 Replacing Sensor Module Door
3-9
3.11 Internal Tubing Harness

Use the following procedure to replace the internal tubing harness.
2. Remove the analyzer cover and set aside.
3. Remove the 4 indicated cover screws. Then detach the cover plate to access
the internal tubing.
4. To remove the Calibrator Cartridge tubing, loosen the 2 indicated screws.
5. Slide the retraining plate upwards. Then tighten the screws to hold into place.
6. Remove the needle shrouds using the access hole then disconnect from the
Rotary valve and Coil. Disconnect the Waste and Reference lines from their
fittings at the top of the analyzer
7. To remove the Internal QC tubing,
disconnect each line from the control
manifold and the Rotary valve.
8. Remove the Common Line from the Rotary
Valve and the Fluid Fountain.
Figure 3.16 Replacing Internal Tubing Harness
3-10
4 Troubleshooting
4.0 Troubleshooting
This section describes the recommended troubleshooting procedures for use with
the Stat Profile Prime CCS analyzer. The procedures use the most logical and di-
rect steps to resolve each problem and are written to minimize the replacement of
any unnecessary parts. If the recommended solutions do not resolve the problem
please contact Nova Biomedical Technical Support for troubleshooting assistance.
FOR TECHNICAL ASSISTANCE, CALL TOLL FREE:
USA 1-800-545-NOVA
Canada 1-800-263-5999
Other Countries Contact the local Nova Biomedical Sales Office or
Authorized Nova Biomedical Distributor
4. Trouble.
WARNING:
Blood samples and blood products are potential sources of
infectious agents. Handle all blood products and flow path
components (waste-line, capillary adapter, probe, sensor cartridge,
etc.) with care. Gloves and protective clothing are recommended.
When performing maintenance and troubleshooting procedures,
also use protective eyewear.
4-1
4.1 Event Log

The Event Log displays a list of events that have occurred during a selected time
frame. To access the Event Log; from the Home Screen, press
, , , .
The Event Log initially displays events that occurred on the current date but may
be changed to show events that occurred during a specified time frame or that
contain a specific Event ID. Events are displayed chronologically with the most
recent event at the top of the page. Each event is shown with the date and time
the event occurred, the event ID and a description of the event. To view additional
details of a specific event, select (highlight) the event of interest then press the
Details button . To print the Event Log press .
Figure 4.1 Event Screen
4.2 Resolving Event Codes

Event Codes are grouped into 5 categories:
Cartridge errors, Flow errors, Printer errors, Micro Sensor Card errors, and Hard-
ware/Software errors. Use the following troubleshooting steps to resolve the listed
codes. If a displayed code is not listed please contact Nova Biomedical Technical
Support for assistance.
4-2
4 Troubleshooting
4.2.1 Flow Event Codes
Event
Code Description and Corrective Action
602 Insufficient Sample – During the last sample analysis, the leading edge of
the sample was not detected at the reference air detector when expected.
Recommended Solution
1. Rerun the sample and insure the sample probe is not being obstructed
by the sample container.
2. Flush the flow path with deionized water and recalibrate the analyzer.
Refer to Section 4.7.1, Flushing the Flow Path.
3. Replace the W/R Pump Harness.
4. Trouble.
4. Contact Nova Biomedical Technical Support.
604 No Flush When Required – During the last calibration or sample analysis,
Flush solution was not detected when expected.
1. Verify the % remaining in the Calibrator Cartridge. If the pack indicates
less than 10% remaining, replace the Calibrator Cartridge.
3. Calibrate the Air Detector.
605 No Air When Required - During the last calibration or sample analysis,
Air was not detected when expected.
Refer to Section 4.7.1, Flushing the Prime Flow Path.
4-3
606 No Standard A When Required - During the last calibration or sample

analysis, calibrator standard A solution was not detected when expected.
607 No Standard B When Required - During the last calibration, calibrator

standard B solution was not detected when expected.
608 No Internal QC When Required – During the last Internal QC analysis,
QC solution was not detected when expected.
1. Verify the % remaining in the Internal QC Cartridge. If the pack indicates
less than 10% remaining, replace the QC Cartridge.
4-4
4 Troubleshooting
609 No Sample When Required – During the last sample analysis, no sample
was detected by the analyzer.
Recommended Solutions
1. If analyzing a whole blood sample, verify that the sample is not clotted.
If the sample is clotted, Nova Biomedical recommends that the sample
be redrawn or that a clot catcher be utilized prior to repeating the
analysis.
2. If analyzing an external QC sample, repeat the analysis. If the problem
recurs, proceed to step 3.
4. Trouble.
611 Sample Position Not Confirmed – During the last analysis, the sample
was not detected at one of the air detectors.
Recommended Solutions
1. If analyzing a whole blood sample, verify that the sample is not clotted.
If the sample is clotted, Nova Biomedical recommends that the sample
be redrawn or that a clot catcher be utilized prior to repeating the
analysis.
2. If analyzing an external QC sample, repeat the analysis. If the problem recurs,
proceed to step 3.
4-5
4.2.2 Printer Event Codes
Event
904 Printer Paper Out – No paper was detected in the thermal printer.
1. Check and or replace printer paper supply.
2. Contact Nova Biomedical Technical Support if printer paper is not
recognized.
905 Printer Cover Open – The printer cover is not completely closed.
1. Insure the printer cover is fully closed.
2. Contact Nova Biomedical Technical Support if unable to resolve.
906 Printer – A printer error has occurred.
1. Check the printer paper supply. Clear any paper jam that may have
occurred.
2. Contact Nova Biomedical Technical Support if unable to resolve.
4-6
4 Troubleshooting
4.2.3 Micro Sensor Card Event Codes
Event
1201 Slope The measured

1209 pH Slope difference between
1217 pO2 Slope the indicated analytes’
1225 pCO2 Slope calibration standards did
1233 K Slope not meet the minimum
1241 Na Slope specifications for a
1249 Cl Slope properly performing
1257 Ca Slope sensor during the last
1265 Hct Slope 2-point calibration.
1289 Glucose Slope
4. Trouble.
1297 Lactate Slope
1. Recalibrate the analyzer.
2. Flush the flowpath and recalibrate the analyzer. Refer to Section 4.7.1
Flushing the Flowpath.
3. Replace the Micro Sensor Card.
4. Replace the Calibrator Cartridge.
5. Replace the Reference Sensor.
6. Call Nova Biomedical Technical Support.
1202 Overload During the last

1210 pH Overload calibration or analysis
1218 pO2 Overload sequence, the indicated
1226 pCO2 Overload analytes’ sensor reading
1234 K Overload exceeded the software
1242 Na Overload limits.
1250 Cl Overload
1258 Ca Overload
1266 Hct Overload
1290 Glu Overload
1298 Lac Overload
4-7
1205 Stability During the last

1213 pH Stability calibration or analysis
1221 pO2 Stability sequence, the indicated
1229 pCO2 Stability analytes’ sensor did not
1237 K Stability reach a stable endpoint.
1245 Na Stability
1253 Cl Stability
1261 Ca Stability
1269 Hct Stability
1293 Glu Stability
1301 Lac Stability
4. Replace the Reference Sensor.
1206 E-Zero Drift During the last analysis
1214 pH E-Zero Drift sequence, the indicated
1222 pO2 E-Zero Drift analytes’ performance
1230 pCO2 E-Zero Drift changed significantly
1238 K E-Zero Drift since the last successful
1246 Na E-Zero Drift 2-point calibration.
1254 Cl E-Zero Drift
1262 Ca E-Zero Drift
1270 Hct E-Zero Drift
1294 Glu E-Zero Drift
1302 Lac E-Zero Drift
2. If the problem persists, flush the flowpath and recalibrate the analyzer.
Refer to Section 4.7.1 Flushing the Flowpath.
4-8
4 Troubleshooting
1207 A to A Drift During the last analysis

1215 pH A to A Drift sequence, the indicated
1223 pO2 A to A Drift analytes’ performance
1231 pCO2 A to A Drift changed significantly
1239 K A to A Drift from the previous
1247 Na A to A Drift analysis.
1255 Cl A to A Drift
1263 Ca A to A Drift
1271 Hct A to A Drift
1295 Glu A to A Drift
1303 Lac A to A Drift
4. Trouble.
Refer to Section 4.7.1 Flushing the Flowpath.
1208 Slope Drift During the last
1216 pH Slope Drift calibration, the indicated
1224 pO2 Slope Drift analytes’ performance
1232 pCO2 Slope Drift changed significantly
1240 K Slope Drift from the previous
1248 Na Slope Drift calibration.
1256 Cl Slope Drift
1264 Ca Slope Drift
1272 Hct Slope Drift
1296 Glu Slope Drift
1304 Lac Slope Drift
4-9
4.3 Troubleshooting Flow Problems

The analyzer may experience flow problems as a result of aspirating clots from
poorly heparinized whole blood samples. If this should occur operators can use
the following procedures to clear the analyzer flowpath and verify the analyzer is
capable of aspirating from the sample probe.
NOTE: Nova Biomedical recommends but does not require the use of clot
catchers as an effective means of preventing the aspiration of clots into
the analyzer’s flowpath.
4.4 2-Point Calibration Sequence

The 2-point calibration sequence calibrates the sensors in the sensor cartridge.
Any sensor that does not respond within the software’s limits will fail calibra-
tion and become unavailable for analysis. The 2-point calibration is performed as
shown below.
1. Pump Flush for 4 seconds. Then move the rotary valve to air and pump until
air is detected at AD-1.
2. Read Sensors on Flush solution.
3. Pump air/Cal A segments.
4. Pump Calibrator A for 4 seconds. Then move the rotary valve to air and pump
until air is detected at AD-1.
5. Read Sensors on Calibrator A.
6. Pump air/Flush segments.
7. Pump Cal B/air segments.
8. Pump Calibrator B for 4 seconds. Then move the rotary valve to air and pump
until air is detected at AD-1.
9. Read Sensors on Calibrator B.
10. Pump air/Flush segments.
11. Pump Flush for 5 seconds to refill flowpath.
12. Read Sensors on Flush solution.
4.5 Analysis Sequence

The analysis sequence will vary by sample type and the model of analyzer. The se-
quence shown below is specific to the Prime CCS analyzer however other models
will follow similar sequences when running Patient and QC samples.
1. Pump air to AD-1.
2. Operator presses ANALYZE.
3. If the sample type is Whole Blood, aspirate sample to AD-2.
4. If the sample is External QC or Proficiency, aspirate sample to AD-Mid.
5. If the sample is Internal QC, pump QC for 4 seconds.
6. Move the rotary valve to air and pump until air is detected at AD-1.
7. Start reading Hct.
4-10
4 Troubleshooting
8. Pump air until air is detected at AD-2.

9. Stop pump, check AD-Ref and AD-Hct for sample.
10. Read Sensors.
11. Pump Flush/air segments.
12. Pump Cal A/air segments.
13. Pump Calibrator A for 5 seconds then then move the rotary valve to air and
pump until air is detected at AD-1.
14. Read Sensors on Calibrator A (1-Point Calibration)
15. Pump Flush/air segments
16. Pump Flush for 5 seconds to refill the flowpath.
4.6 Service Menu

The Service Menu provides a means of priming the Calibrator and Auto QC Car-
tridges, calibrating the Air Detectors, verifying the Software Version, the signal
4. Trouble.
strength from each RFID sensor and manually moving the analyzer’s electro-me-
chanical subsystems.
To access the Service Menu, from the Home screen press , ,

.
Figure 4.2 Service Screen
- Press Prime Calibrator to prime all the fluids in the Calibrator

Cartridge.
- Press Prime Auto QC to prime Internal QC levels 1, 2 and 3.
4-11
- Air detectors are calibrated once per day and, if the correct
replacement procedure is followed, after replacing the Sample Probe/S-line, Refer-
ence Sensor or Sensor Cartridge. In the event the replacement procedure was not
followed the air detectors can be recalibrated using this function.
- Press Credits to display the credit status (if any) for the
Sensor Cartridge.
Figure 4.3 Credits Screen
- Press Software Version to display the installed software

version of the GUI, Control, and Sensor processors.
Figure 4.4 Software Version Screen
4-12
4 Troubleshooting
- Press RFID to display the RFID signal strength from the

Sensor Cartridge, Calibrator Cartridge, and QC Cartridge. 0 indicates no signal; 7
indicates maximum signal strength. Typically signal strength should be 4 to 7.
NOTE: Below 4, the RFID read/write ability may be compromised.
4. Trouble.
Figure 4.5 RFID Screen
- Press Diagnostics to enable a way to move the Sampler, Ro-

tary Valve, and Pump assemblies, to verify system temperatures, to view real time
readings from the air detectors and sensor cartridge.
Figure 4.6 Diagnostics Screen
Temperature errors will occur if the temperature exceeds specifications.

Hematocrit: 37° C +/- 0.5° C
Door, Nest, and Coil: 37° C +/- 0.3° C
4-13
To turn on the Pump

1. First press the Pump Speed button.
2. Select the desired speed from the pop-up menu.
3. Press the Run Pump button to start the pump.
4. Press again to stop the pump.
Figure 4.7 Diagnostics Screen: Turn On the Pump Buttons
To move the Rotary Valve

1. Press the Rotary Valve button.
2. Select a position from the pop-up window.
NOTE: The pop-up window will remain visible until closed by pressing the at
the bottom of the window.
Figure 4.8 Diagnostics Screen: Turn On the Rotary Valve Buttons
4-14
4 Troubleshooting
To move the Sampler Assembly

1. Press the Sampler button.
2. Select a position from the pop-up window.
NOTE: The pop-up window will remain visible until closed by pressing the at
the bottom of the window.
4. Trouble.
Figure 4.9 Diagnostics Screen: Move the Sampler Assembly Buttons
4-15
4.7 The Flow Path Flush Tool

The Flow Path Flush Tool consists of a 30 mL syringe and a special adaptor to
safely clear the flowpath in the event it becomes obstructed.
Figure 4.10 Flowpath Flush Tool
The tool can be used with or without the adaptor to flush individual flow path com-
ponents. The adaptor is keyed to connect to the Reference Sensor in only one
direction as shown. The tubing connected to the adaptor should point up to ensure
it is not pinched shut when the Micro Sensor Card door is closed.
Figure 4.11 Tubing Connected to the Adapter Points Up
4-16
4 Troubleshooting
4.7.1 Flushing the Flowpath

The analyzer’s flowpath can be flushed to remove clots or other debris that may
have been aspirated into the system. Use of a device other than the Flush Tool
may damage the Micro Sensor Card and is not recommended.
The following is the recommended procedure for clearing the flowpath when needed.
1. From the Home screen, press then .
2. When the pump stops turning, open the analyzer door then open the Micro
Sensor Card door.
3. Aspirate a small amount of deionized water into the Flow Path Flush Tool.
4. Disconnect the W/R Pump Harness from the Reference Sensor.
4. Trouble.
Figure 4.12 Flush Flowpath Screens
5. Connect the Flush Tool to the Reference Sensor and

close the Micro Sensor Card door.
6. Using moderate pressure, carefully flush the flowpath
with 1-2 mL of deionized water into a container placed
in front of the sample probe.
7. Refill the Flush Tool with air and flush the flow path
to remove any remaining liquid.
8. Disconnect the Flushing Tool and reattach the W/R
tubing harness to the Reference Sensor.
9. Close the Micro Sensor Card door and press Done.
10. Recalibrate the analyzer 3 times.
Figure 4.13 Flushing Flowpath into Gauze
4-17
4.7.2 Flushing the Sample Probe/S-Line

The Sample Probe is designed to prevent large clots and other debris from ad-
vancing into the analyzer’s flowpath if possible. As a result, the sample probe may
become obstructed and require manual flushing to remove an obstruction.
The following is the recommended procedure for clearing obstructions from the
sample probe and S-line.

2. When the pump stops turning, open the analyzer door.
3. Draw a small amount of deionized water
into the Flow Path Flush Tool.
4. Carefully disconnect the Sample
probe/S-line tubing from the bottom of
the Reference Sensor using the removal
tool.
5. Slide the flush tool tubing over the
extended sample probe.
6. Using moderate pressure, flush water
through the sample probe and S-line
into a container or gauze placed in front
of the S-line.
7. Refill the Flush Tool with air and flush the
sample probe to remove any remaining
liquid.
8. Press Done when finished.
9. Recalibrate the analyzer as needed.
Figure 4.14 Flushing the S-Line
4-18
4 Troubleshooting
4.7.3 Flow Test

The following procedure can be used to verify the analyzer is able to aspirate from
the sample probe. Use this procedure in tandem with the flushing procedures to
clear obstructions and verify flow.

2. Once the pump stops and the sample probe has been extended press
to scroll down to page 2.
3. Fill a small container with deionized water and immerse the sample probe into
the water.
4. Press on the display to start the peristaltic pump. The water level
in the container should drop quickly if the analyzer is aspirating correctly.
5. Press Done when finished.
4. Trouble.
6. Recalibrate the analyzer as needed.
Figure 4.15 Flow Test
4-19
Figure 4.16 Interconnect Diagram
4-20
4 Troubleshooting
4. Trouble.
Figure 4.17 Flowpath Diagram
4-21
4.8 Software Updates

The Prime software was designed to be updated easily using an external USB
drive. The procedure below steps through the installation process.
To successfully upgrade your Stat Profile Prime, you will need a USB Stick that
meets the following minimum specification.
Figure 4.18 USB Stick Specification
1. Unzip the file into the root directory of the USB drive. Do not create a directory
for the software and ensure the USB drive does not contain any security
software or password requirements.
2. Power down the analyzer by disconnecting the power cord from the back of
the analyzer. Insert the memory stick onto the USB port located on the left
side of the front door and reboot the device by reconnecting the power cord
on the rear of the analyzer.
3. During boot up the device will boot up to the screen shown below. Upgrade
the software by pressing the green arrow key on the bottom right hand side
of the screen.
4. The system will upgrade the GUI and the host versions. Once complete you
will be at the same upgrade screen.
4-22
4 Troubleshooting
Figure 4.19 Software Update Screen
5. Power down the analyzer and remove the USB stick.
4. Trouble.
6. Power up the analyzer and confirm it is functioning normally.
4.9 Long Term Shutdown

The Prime can be safely shut down for several hours without taking any special
precautions however, if the analyzer is to be shut down for a longer period the fol-
lowing shut down procedure is strongly recommended.
1. Remove the Calibrator Cartridge and Internal QC Cartridge from the analyzer.
2. Insert the Prime Flush Fixture (REF 52865) into the calibrator cartridge bay
and the Control Flush Fixture (REF 24819) into the Internal QC cartridge bay.
3. Place the waste line (labeled with a W) into an empty container. Place the
remaining tubing lines into a container of deionized water.
4. From the Home screen press
, , .
5. Press Pump Speed and select .
6. Press Rotary Valve and select .
7. Press and allow the pump to run long enough to ensure water
has passed through the entire flowpath and into the waste container.
8. Repeat steps 6 and 7 selecting Standard A, Standard B, and OBC (On Board
Control) 1, 2 and 3.
9. Remove the tubing lines from the container of deionized water and repeat
Steps 6, 7, and 8 until all water has been flushed from the system.
10. Remove the Flush Fixtures, remove the pump tubing harness from the pump,
and power off the analyzer.
4-23
4-24

Prime Service Manual PN54460A (2020 - 08 - 20 02 - 50 - 44 UTC)

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54460

Stat Profile® PRIME™

Stat Profile® Prime™ CCS Service Manual

Technical Assistance (USA)

Tel: 1-800-545-NOVA or FAX: (781) 894-0585

2 Analyzer Components 2-1

3.0 Replacement Procedures 3-1

4.0 Troubleshooting 4-1

Ambient Operating Temperature:

Lifting the Analyzer:

1.2 Cautions and Hazards

Decontamination of the external surfaces of the flow path may be accomplished by

2.1.1 Power Supply

2.1.2 GUI Board

2.1.3 Main Board

Figure 2.1 Prime Interconnect Diagram

2.2 Fluidic System

Figure 2.2 Prime Flowpath

2.2 Main Component Identification

1. Sensor Module Door (PN 52884) 4. Reference Sensor

Figure 2.3B Main Component Identification

1. Sampler Assembly (PN 52887)

Figure 2.3C Main Component Identification

1. Coil Assembly (PN52889)

Figure 2.3D Main Component Identification

1. Main Board - (PN52895)

Figure 2.3E Main Component Identification

3.0 Replacement Procedures

3.1 Cover Removal

1. Remove the screws and slide the

Figure 3.1 Remove Screws from Back Cover

2. Disconnect the printer cable from the

Figure 3.2 Disconnect the Printer Cable

3.2 Sampler Assembly Replacement

Figure 3.3 Sampler Replacement

3.3 Rotary Valve Replacement

Figure 3.5 Disconnect the J20 and J24 Cables

1. Unplug the analyzer, remove the cover, and set it aside.

Figure 3.6 Coil Replacement

3.5 Main Board

WARNING: NEVER REMOVE cables

3.6 GUI Board

1. To access the GUI Board first remove

Figure 3.9 Remove the 5 Mounting Screws

2. Disconnect the Bar Code

Figure 3.10 Remove the 4 Board Moun

WARNING: NEVER REMOVE cables

3.7 RFID Board

1. Unplug the analyzer, remove the cover, and set it aside.

3.8 Cooling Fan

1. Disconnect the Fan cable from

Figure 3.12 Cooling Fan Assembly Removal

3.9 Nest Housing

Figure 3.13 Remove the 3 Hex Screws

Figure 3.15 Using a Screwdriver to Remove Locking Cap

3.10 Sensor Module Door

Figure 3.15 Replacing Sensor Module Door

3.11 Internal Tubing Harness

Figure 3.16 Replacing Internal Tubing Harness

FOR TECHNICAL ASSISTANCE, CALL TOLL FREE:

4.1 Event Log

Figure 4.1 Event Screen

4.2 Resolving Event Codes